ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
研究概览
简要总结
Currently, the tumor response of operated colorectal liver metastases is assessed by histology of the resection specimen.The histological data make it possible to define categories (responder, partial responder, non-responder).
Overall survival (OS: overall survival) after surgery crucially depends on the response to neoadjuvant chemotherapy. Current criteria for predicting histological response in preoperative imaging are not satisfactory.
The working hypothesis is that it is possible to better differentiate the tissue response to conventional chemotherapies and anti-angiogenics through MRI elastography by quantifying the changes in tissue mechanical properties induced by systemic treatments.
The objectives is to evaluate the mechanical properties obtained by elasto MRI according to the systemic treatments envisaged: conventional chemotherapy such as Folfox or combined with targeted therapy
详细描述
Currently, the tumor response of operated colorectal liver metastases is assessed by histology of the resection specimen.The histological data make it possible to define categories (responder, partial responder, non-responder).
Overall survival (OS: overall survival) after surgery crucially depends on the response to neoadjuvant chemotherapy. Current criteria for predicting histological response in preoperative imaging are not satisfactory.
The working hypothesis is that it is possible to better differentiate the tissue response to conventional chemotherapies and anti-angiogenics through MRI elastography by quantifying the changes in tissue mechanical properties induced by systemic treatments.
The objectives is to evaluate the mechanical properties obtained by elasto MRI according to the systemic treatments envisaged: conventional chemotherapy such as Folfox or combined with targeted therapy
This is an open, non-randomized, non-comparative trial with three parallel groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥18 years old, followed for colorectal cancer with hepatic metastases.
- •The diagnosis of metastasis can be made: either by tumor biopsy or by the appearance during follow-up of colorectal cancer of at least one liver lesion with the characteristics of metastasis (fibrous tumor type imaging)
- •Patient with an indication to receive first-line chemotherapy for liver metastases, whether or not associated with targeted therapy
- •Patient with at least one hepatic metastasis greater than 2cm
排除标准
- •Patients not affiliated with social security
- •Pregnant or breastfeeding women
- •Patients under guardianship, curatorship or safeguard of justice
- •Patients with a contraindication to MRI or to the injection of contrast agent in MRI. The classic contraindications for MRI are defined by the French Society of Radiology:http://www.sfrnet.org/sfr/professionnels/1-fiche-information-patients/irm/index.phtml
- •Lack of signed patient consent
结局指标
主要结局
Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
时间窗: 6 months
The Primary endpoint is variation in the measurement of the elasticity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response criteria RECIST1.1
Evaluate viscosity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
时间窗: 6 months
The Primary endpoint is variation in the measurement of the viscosity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response criteria RECIST1.1
次要结局
- Compare the type of tumor response of liver MRI with liver CT(Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups)
- Correlate in operated patients the mechanical properties obtained by elastomeric MRI with the histological response.(by preoperative)
- Compare the metastases detected of liver MRI with liver CT(Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups)
- Compare tumour response of liver MRI with liver CT(Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups)